Valve system for introducing objects into anatomical body portions

ABSTRACT

A valve assembly adapted for introduction of an elongated object into a patient&#39;s body having a first valve formed of a resilient material and defining an aperture for reception of the object, the aperture being configured and dimensioned such that insertion of the object into the aperture will cause the resilient material defining the aperture to resiliently engage the outer surface of the object in a fluid tight manner. A second valve is positioned adjacent and distal of the first valve in general alignment therewith, whereby the second valve defines an aperture in general alignment with the aperture of the first valve, and is formed of a flexible material at least in the region defining the aperture. A pair of manually operable clamps are provided to selectively permit the aperture of the second valve to be opened or closed so as to permit entry of the object such that the object first passes through the first valve and then the second valve prior to entry into the patient&#39;s body.

This is a continuation of copending application Ser. No. 07/711,756filed Jun. 7, 1991 now U.S. Pat. No. 5,120,373.

BACKGROUND OF THE INVENTION

1. Field Of The Invention

This invention relates to valve systems of the type adapted to allow theintroduction of a surgical instrument into a patient's body. Inparticular, the invention is applicable to a cannula assembly and thelike wherein a cannula extends from a valve assembly and is intended forinsertion into a patient's body and an instrument is inserted into thepatient's body through the cannula.

2. Background Of The Prior Art

In laparoscopic procedures surgery is performed in the interior of theabdomen through a small incision; in endoscopic procedures surgery isperformed in any hollow viscus of the body through narrow endoscopictubes or cannula inserted through a small entrance incision in the skin.Laparoscopic and endoscopic procedures generally require that anyinstrumentation inserted into the body be sealed, i.e. provisions mustbe made to ensure that gases do not enter or exit the body through thelaparoscopic or endoscopic incision as, for example, in surgicalprocedures in which the surgical region is insufflated. Moreover,laparoscopic and endoscopic procedures often require the surgeon to acton organs, tissues, and vessels far removed from the incision, therebyrequiring that any instruments used in such procedures be relativelylong and narrow.

For such procedures, the introduction of a tube into certain anatomicalcavities such as the abdominal cavity is usually accomplished by use ofa system comprised of a cannula assembly and a trocar. A cannulaassembly is formed of a cannula attached to a valve assembly which isadapted to maintain a seal across the opening of the valve assembly.Since the cannula is in direct communication with the internal portionof the valve assembly, insertion of the cannula into an opening in thepatient's body so as to reach the inner abdominal cavity should beadapted to maintain a fluid tight interface between the abdominal cavityand the outside atmosphere.

Since surgical procedures in the abdominal cavity of the body requireinsufflating gases to raise the cavity wall away from vital organs, theprocedure is usually initiated by use of a Verres needle through which agas is introduced into the body cavity. Thereafter, a trocar, which is asharp pointed instrument, is inserted into a cannula assembly and usedto puncture the peritoneum, i.e. the inner lining of the abdominalcavity wall. The gas provides a slight pressure which raises the wallsurface of the peritoneum away from the vital organs thereby avoidingunnecessary contact with the organs by the instruments inserted into thecannula. This procedure also provides the surgeon with an adequateregion in which to operate. Laparoscopic or endoscopic surgicalinstruments may then be inserted through the cannula to perform surgerywithin the abdominal cavity or other body portion. The cannula is alsoutilized for introducing tubes into the body as for drainage purposes orthe like.

In view of the need to maintain the atmospheric integrity of the innerarea of the cavity, a valve assembly which permits introduction of atrocar or any surgical instrument and which permits selectivecommunication of the inner atmosphere of the cavity with the outsideatmosphere is desirable. In this regard, there have been a number ofattempts in the prior art to provide such atmospheric integrity.

One form of cannula assembly includes a valve assembly which includes aflapper valve which is pivotally mounted within the valve assembly andis automatically opened by the trocar or other object when it isinserted into the proximal end of the valve assembly. See, e.g., U.S.Pat. No. 4,943,280 to Lander.

U.S. Pat. No. 4,960,412 relates to a catheter introducing system whichincludes a valve assembly having dual flexible resilient gaskets whichpermit introduction of a catheter by providing dual openings which aredimensioned to contact a catheter tube introduced into the unit.Introduction of the tube is accomplished by introducing the tube intothe openings of the gaskets. A first valve prevents or minimizes theflow of blood from the valve assembly unit when the catheter tube isabsent and the second valve prevents or minimizes the flow of blood fromthe valve assembly when the catheter tube is present.

Another valve includes finger operated levers for controlling an innervalve formed of a plurality of radially movable members which join inadjacent relation to close the valve opening and which separate topermit entry of an element into the valve opening. The members areconcentrically positioned and arranged to block the opening when thelevers are at rest and to open in a manner to form a substantiallycircular passage-way when the levers are squeezed toward each otheragainst the bias of a spring positioned therebetween.

Although attempts have been somewhat successful in providing a valveassembly which maintains the integrity of the atmospheric interfacebetween the inlet of the valve assembly and the atmosphere outside thevalve assembly, none have provided the degree of control to the userwhereby opening adapted to facilitate the introduction of an instrumentinto the human body can be controlled selectively, opened or closed, insequence and in a manner which positively retains the desired interfacebetween the two atmospheres as may be required by the operator. Thepresent invention provides a valve assembly which may be incorporatedinto a cannula assembly or utilized in combination with any type oftubular member for introduction into the body of a patient whilepermitting introduction of instruments into the body. At all times, thesurgeon maintains control over the interface between the atmosphereswithin and without the patient's body. Moreover, the present inventionmakes it possible to introduce instruments of varying sizes into thebody and insures the maintenance of a gas seal despite instrumentmanipulation therethrough.

SUMMARY OF THE INVENTION

A valve assembly adapted for introduction of an elongated object into apatient's body is provided which comprises first valve means formed of aresilient material and defining an aperture for reception of the object,the aperture being configured and dimensioned such that insertion of theobject into the aperture will cause the resilient material defining theaperture to resiliently engage the outer surface of the object in asubstantially fluid tight manner. Second valve means is positionedadjacent the first valve means in general alignment therewith, thesecond valve means defining an aperture in general alignment with theaperture of the first valve means and being formed of a flexiblematerial at least in the region defining the aperture. Means is providedto selectively permit the aperture of the second valve means to beopened or closed so as to permit entry of the object.

Preferably, the valve assembly comprises valve body means which definesproximal inlet and distal outlet openings. The first valve means isformed of an elastomeric resilient material and extends across theproximal inlet opening of the valve body, and defines an apertureconfigured and dimensioned for reception of the object in a manner suchthat resilient material surrounding the aperture engages the surface ofthe object to provide a substantially fluid tight seal which preventspassage of fluids past the interface. The second valve means ispositioned adjacent and distally of the first valve means and both valvemeans extend across the proximal inlet opening of the valve body. Thesecond valve means includes an aperture defined at least in part byflexible elastomeric material in general alignment with the aperture ofthe first valve means and of dimension sufficient to permit passage ofthe object after the object is passed through the first valve means.Means is provided to bias the flexible material defining the aperture ofthe second valve means to a configuration whereby the aperture is closedto form a fluid tight seal prior to inserting the object therethrough,and means is provided to open the aperture of the second valve means topermit passage of the object therethrough after the object is passedthrough the first valve means. Preferably, means to open the aperture ofthe second valve means is manually operable.

The objects contemplated are surgical instruments such as clip appliers,dissectors, graspers, laser and electrocautery devices, drainage orfluid introduction tubes or the like. The first valve means ispositioned across the proximal opening of the valve body and the secondvalve means is positioned adjacent the first valve means and distallythereof. Further, the first and second valve means are preferably formedintegrally of a flexible elastomeric resilient material, with the firstvalve means connected to the second valve means at the proximal endsthereof, the first valve means being positioned at least partiallywithin the second valve means. The first and second valve means arejoined at their proximal ends and are attached to the valve body acrossthe proximal opening. The valve body includes a neck which extendsdistally of the distal end thereof, the neck defining an openingcommunicating with the interior of the valve body means. Further, thedistally extending neck of the valve body is adapted to receive atubular cannula such that the cannula extends distally of the valvebody.

The second valve means comprises an elastomeric generally cylindricallyshaped member which is preferably connected integrally at the proximalend thereof to the proximal end of the first valve means and is open atthe distal end. The distal opening of the second valve means is capableof being closed by collapsing the distal end until the half portionsthereof resiliently contact each other to form a substantial fluid tightseal. The distal end of the second valve means is biased toward theclosed fluid tight position by a clamp which is positioned and adaptedto bias the open end of the second valve means toward the collapsedconfiguration. The clamp comprises a pair of clamp blades, each bladeconnected to a portion of the distal open end of the second valve means.The clamp blades are each biased toward each other to close the distalopening of the second valve means by a respective torsion spring mountedwithin the valve body. Each clamp blade is connected to a pivotal armand each pivotal arm is biased toward the position corresponding to theclosed position of the second valve means. The pivotal arms are mountedfor pivotal movement toward the valve-open position by reception into anaperture of at least one slidable pin. The pins are movable manually byengagement by the user's fingers.

The first and second valve means are preferably attached to andsupported by an annular ring which includes a plurality of elongatedfingers which extend distally therefrom and are positioned within thefirst valve means in contact with the inner surface thereof. The fingersprovide an interface between the first valve means and objects insertedtherein and assist in spreading the opening of the first valve means forentry of the instrument. Further, the fingers distribute the force overthe inner surface of the first valve means.

Each slidable pin has a frusto-conical shaped tip adjacent each pivotarm for engagement with the respective pivot arm when the pins are movedtoward each other by manual action of the user. Further, the valve bodyis preferably a two piece valve housing assembled at a medial interfaceand constructed of a relatively rigid plastic material such aspolycarbonate, polyethylene or the like.

In a preferred embodiment, a cannula and trocar assembly is provided forpuncturing a body wall of a patient for the introduction of elongatedobjects as surgical instruments or the like into the body of the patientwhile maintaining a substantial fluid tight seal between internal bodyportions and the outside atmosphere at all times prior to and afterinsertion of the object. The valve housing has an inlet opening at theproximal end and an outlet opening at the distal end, the distal endopening having a tubular cannula extending distally therefrom. A trocaris positioned within the valve housing and the cannula for puncturingthe body wall. Thereafter, the trocar is removed and elongated objectssuch as surgical instruments or the like may be introduced into thepatient's body through the valve assembly and cannula as describedhereinabove.

In the preferred embodiment the first and second valves are moldedintegrally of synthetic or natural rubber and are connected at a commonproximal end which defines the proximal opening. The first valve meanshas a generally conical shape and is positioned within the second valvemeans in a generally concentric fashion. The valve means are mountedonto a support ring which is used to mount the valve means to an annularportion within the valve housing.

A method is provided for selectively sealing a valve assembly forcommunication with inner portions of a patient's body while permittingintroduction of an elongated instrument therethrough, the valve assemblyhaving a proximal inlet opening and a distal outlet opening, comprisingproviding first valve means comprised of resilient material defining anopening which permits entry therethrough by the instrument whileresiliently contacting the outer surface, providing second valve meansdistal of the first valve means, and selectively controlling the openand closed condition of the second valve means to permit passage of theinstrument after entry through the first valve means.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded perspective view of a cannula assemblyillustrating the valve assembly constructed according to the presentinvention;

FIG. 2 is a view of the lower housing half section shown in FIG. 1 withportions of the inner valve and cannula cut away for illustrationpurposes;

FIG. 3 is a cross-sectional view of the valve assembly of the presentinvention taken along lines 3--3 of FIG. 2; and

FIG. 4 is a cross-sectional view of the valve assembly of the presentinvention, taken along lines 4--4 of FIG. 2.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention contemplates introduction into a patient's body ofall types of surgical instruments including clip appliers, lasers,photographic devices, tubes, etc. All such objects are referred toherein as "instruments".

Referring initially to FIGS. 1 and 2, a cannula assembly 10 isillustrated having the novel valve assembly 12 constructed according tothe present invention. Valve assembly 12 includes a valve housing 15formed of upper housing half section 14 and lower housing half section16 shown separated in FIG. 1 for convenience of illustration.

The housing half sections 14,16 are formed of a suitable desirableplastic material such as polycarbonate, polyethylene or the like. Onepreferred material is LEXAN brand polycarbonate manufactured andmarketed by General Electric Company, Pittsfield, Mass. The housing halfsections 14,16 are normally attached along the seam by suitableattachment techniques such as adhesive, ultrasonic welding, or the like.

The valve housing 15 includes neck 18 at the distal end having anaperture 20 dimensioned for reception of an appropriate sheath tube suchas cannula 22 to form the cannula assembly 10. The proximal end of valvehousing 15 includes inlet opening 24 which includes annular partition 26for supporting a dual diaphragm as will be described.

Referring now to FIG. 2, the lower housing half section 16 is shown withthe upper housing half section 14 removed, so as to illustrate the novelinner valve mechanism of the present invention. The valve mechanism isshown partially cut away and in cross section. Dual flexible elastomericsealing diaphragm 30 extends across the aperture 20 of housing 15 asshown. The diaphragm 30 forms a circular rib 33 which fits tightly bysnap fit onto annular partition 26 with dual flanged circular rib 32 asshown in FIG. 2. The annular partition 26 is constructed of the samerelatively rigid plastic material such as polycarbonate, polyethylene orthe like, as the valve housing, while diaphragm 30 is constructed of anelastomeric material such as synthetic or natural rubber. Diaphragm 30is of dual walled construction as shown, with the inner wall 30a havinga central aperture 34 for reception of an instrument as will bedescribed.

Referring now to FIG. 1 in conjunction with FIGS. 3 and 4, outer wall30b has formed at the distal end, a pair of ears 36,38 which areconnected to clamp blades 40,42 as shown, by suitable pivot pins 44,46and attachment nuts 43,47. Each clamp blade 40,42 is biased in adirection toward the other by a torsion spring 48,50 having one leg inengagement with the adjacent housing wall and the other leg inengagement with pivotal arm 52,54 respectively pivotally mounted atpivot pin 56,58 as shown in FIG. 3. Each pivot arm 52,54 extends asshown, into the path of a pin 60,62 which is slidably mounted withinelongated opening 64,65 having a circular cross-section similar to thecross-section of the pins 60,62. The inner end of each pin has anopening 66,68 for reception of the appropriate pivotal arm 52,54 suchthat manually depressing the slidable pins 60,62 toward each other byengagement of transverse buttons 70,72 with the thumb and index fingercauses pivotal arms 52,54 to pivotally rotate arms 52,54 away from eachother. This motion causes clamp blades 40,42 with ears 36,38 to separatecausing outer wall 30b of dual diaphragm 30 to open at the distal end tothe configuration shown in FIG. 1. When the pins 60,62 are released, theouter wall 30b of diaphragm 30 collapses to the configuration shown inFIGS. 3 and 4 under action of clamp blades 44,46 and springs 48,50, thuscausing outer wall to collapse to the duckbill shape 74, providing afluid tight seal between the proximal end of the diaphragm 30 and thedistal end.

Referring now to FIG. 4 in conjunction with FIG. 1, inner elastomericwall 30a of diaphragm 30 defines circular central aperture 34 at thedistal end which is dimensioned less than or equal to the outer diameterof any instrument intended for entry into the proximal end of the valveassembly. Preferably, diaphragm 30 is fabricated from a material whichis sufficiently resilient to accommodate and provide a fluid seal withinstruments of varying diameters, e.g., diameters of from 5 mm to 10 mm.In FIG. 1 an endoscopic clip applying apparatus is shown at 76. However,any elongated relatively narrow instrument is contemplated.

Referring once again to FIG. 3 in conjunction with FIG. 1, diaphragmmounting and stabilizing device 31 is formed of dual flanged circularribbed ring 32 having distally extending fingers 78 tapered at theirfree ends as shown. Diaphragm 30 is mounted to dual flanged circularring 32 as shown in FIG. 4 and the entire assembly is mounted to annularpartition 26 as shown. Fingers 78 are positioned within diaphragm innerwall 30a and are sufficiently flexible to conform to the shape of theinner wall while providing some degree of stability to the inner wall.Fingers 78 also assist in spreading inner wall 30a to expand aperture 34when an instrument is inserted by distributing the spreading force moreevenly. In addition to facilitating expansion of aperture 34 to conformto instrument 76, fingers 78 minimize the risk of damage to elastomericinner wall 30a, e.g., puncture thereof, by providing an interfacebetween the instrument 76 and the inner wall. Stabilizing device 31 isfabricated of a suitable flexible plastic material such as polyester,polypropylene, etc. and fingers 78 are preferably formed integral withdual flanged ring 32. Further, fingers 78 are sufficiently thin andflexible such that insertion into inner wall 30a of diaphragm 30 causesthem to assume an initial arcuate shape as shown in FIGS. 2 and 4,similar to the generally conical shape of inner wall 30a.

Upon insertion of instrument 76 into housing opening 20 and throughaperture 34 of inner wall 30a, the elastomeric material of wall 30a willexpand or stretch around the instrument 76 to form a fluid tight seal.The seal is of sufficient fluid tight character that media such aspressurized gases used to insufflate a body cavity or body liquids willnot pass the interface between diaphragm inner wall 30a and theinstrument 76. Aperture 34, in its non-expanded or non-stretchedcondition, is typically approximately 3 to 15 mm to accommodateelongated endoscopic instruments while maintaining sufficient sealedcontact with the other surface thereof. However, such dimensions willvary depending upon the size of the instruments and the intendedapplication. Further, manipulation of the instrument in any directionwill not affect the seal, since the elastomeric material will remain intight contact with the outer surface of the instrument.

At the point when the instrument 76 has passed the inner wall 30a andentered aperture 34, a gas tight seal has been created between theinstrument and the inner wall 30a. The surgeon then squeezes pins 60,62with the thumb and index finger causing the distal end of outer wall 30bof diaphragm 30 to expand to the shape shown in FIG. 1 thus permittingcontinued entry of the instrument 76 through the entire valve bodyhousing 15 and into the cannula 22. Depending upon the particularprocedure, the surgeon may prefer to squeeze pins 60,62 thereby openingouter wall 30b prior to entry of instrument 76 into the valve housing 15and into diaphragm inner wall 30a.

Cannula 22 is connected to the distal end of the valve housing at neck18 which has a series of alternating circular shaped ribs 80 and valleys82. Cannula 22 is fabricated of a rigid material such as a plastic,fiberglass or metal and is supported in position as shown in FIGS. 2 and4 within neck 18 by the ribs 80 which are formed of the same material.Alternatively, the tube 22 may be of elastomeric material in which caseit would simply be flexible and resilient so as to be assembled withdistal neck 18 by inserting the tube into the neck and distorting theouter shape until it is snapped into position as shown within ribs 80.

The operation of the valve assembly will now be described. The valveassembly is intended to be supplied as part of a cannula assembly, i.e.a valve assembly with distal cannula tube 22 positioned as shown. Atrocar is a sharp pointed instrument usually fitted within a cannulaassembly and used to insert the cannula into a body cavity by firstpiercing an aperture in the cavity wall (i.e., the peritoneum). Thecannula is then inserted into the punctured body wall of the patient.Thereafter, the trocar is removed, permitting insertion of instrumentsinto the patient's body through the cannula to perform the desiredprocedure. Thus, the significance of providing control to the surgeon ofthe sealed state of the opening in the cannula assembly cannot beover-emphasized. Such opening will ultimately control the exposurebetween the internal part of the body cavity and the outside atmosphere.For laparoscopic procedures the valve assembly will preserve the stateof insufflation of the peritoneum during the surgical procedures.

The surgeon removes the trocar from the cannula assembly therebypermitting the opening of outer wall 30b of diaphragm 30 to closeautomatically under the action of springs 48,50. Thereafter, the surgeoninserts an instrument into the body cavity by first inserting it intothe proximal end of the valve assembly, through dual flanged ring 32 andthen through aperture 34 of inner diaphragm wall 30a. Pins 60,62 may beselectively squeezed as desired by the surgeon to open the distal end ofouter wall 30b to permit entry of the instrument into cannula 22 andinto the body cavity. At this point, the tight contact between theinstrument 76 and the diaphragm inner wall 30a at aperture 34 has sealedthe inner body cavity from the outside atmosphere. This seal is providedby the resilient property of the stretched elastomeric materialsurrounding opening 34. Thus, separating clamp plates 40,42 to openouter diaphragm wall 30b to permit entry of instrument 76 into cannula22 does not affect the sealed condition of the inner anatomical cavity.As noted previously, manipulation of the instrument in any directionwill not affect the seal, since the elastomeric material defining theopening 34 will conform to the movements of the instrument and assume anelliptical or other shape necessary to maintain contact.

As noted, aperture 34 is preferably dimensioned between 3 and 15 mm toaccommodate laparoscopic and endoscopic instruments such as clipappliers, laser tubes, photographic instruments, tubes or the like.However, depending upon need or application this dimensional range maybe varied to accommodate any particular instrument.

The opening at the distal end of outer wall 30b is always under thesurgeon's control through pins 60,62 and is adapted to be automaticallyactuated to the closed duckbill shaped position 74 under action ofsprings 48,50 when the surgeon removes the instrument 76 or other objectfrom the valve assembly. Further, manipulation of the instrument 76 doesnot affect the shape of aperture 34 or the sealing contact of inner wall30 or with the instruments because diaphragm 30 is sufficiently flexibleand resilient to maintain contact with the surface of the instrument 76.Thus, during the entire sequence the integrity of the seal between theinside of the body cavity and the outside atmosphere is clearlymaintained at all times.

We claim:
 1. Valve assembly for sealed reception of an elongated object,which comprises:a) valve body defining a longitudinal axis and having atleast one opening configured and dimensioned to permit entry of theelongated object; b) flexible resilient valve member defining anaperture positioned in general alignment with said at least one opening;and c) means associated with said flexible resilient valve member tofacilitate expansion of said aperture to permit entry of the elongatedobject therethrough in sealed engagement therewith, said means tofacilitate expansion of said aperture adapted for radial displacementrelative to said longitudinal axis and positioned to expand saidaperture upon contact with the elongated object as the elongated objectis at least partially inserted into said at least one opening of saidvalve body.
 2. Valve assembly according to claim 1 wherein saidresilient valve member is adapted to engage and conform to the outersurface of the elongated object in substantially fluid tight manner. 3.Valve assembly for sealed reception of an elongated object, whichcomprises:a) valve body having means configured and dimensioned topermit entry of the elongated object; b) flexible resilient valve meansdefining an aperture positioned in general alignment with said entrymeans; and c) relatively rigid means associated with said resilientvalve means and having portions adapted to be displaced relative to acentral axis defined by said valve body upon contact with the elongatedobject as the elongated object is at least partially inserted into saidentry means of said valve body, said portions positioned and dimensionedto expand said aperture to permit entry of the elongated objecttherethrough during displacement of said portions.
 4. Valve assemblyaccording to claim 3 further comprising secondary valve means positionedadjacent said flexible resilient valve means and in general alignmenttherewith, said secondary valve means movable between a first positionwhich blocks entry of the elongated object and a second position whichpermits entry of the elongated object.
 5. Valve assembly according toclaim 4 wherein said secondary valve means comprises at least one membermovable toward and away with respect to a rigid member to respectivelyassume said first and second positions.
 6. Valve assembly according toclaim 5 comprising resilient means to bias said at least one membertoward said rigid member.
 7. Valve assembly according to claim 6 whereinsaid at least one member is adapted to provide a substantially fluidtight seal when in said first position.
 8. Valve assembly according toclaim 7 wherein said at least one member is pivotal between said firstand second positions.
 9. Valve assembly according to claim 5 whereinsaid valve body is a rigid housing.
 10. Valve assembly according toclaim 9 wherein said valve body is a trocar housing.
 11. Valve assemblyaccording to claim 10 wherein the elongated object is a trocar. 12.Valve assembly for introduction of an elongated object into a patient'sbody, which comprises:a) valve body member defining a proximal inletopening and a distal outlet opening; b) first valve member formed of aflexible elastomeric resilient material and defining an aperture forreception of the elongated object, said aperture being configured anddimensioned such that insertion of the elongated object into saidaperture causes said flexible resilient material defining said apertureto resiliently engage and conform to an outer surface portion of theelongated object in substantially fluid tight manner; c) second valvemember positioned adjacent said first valve member and in generalalignment therewith, said second valve member defining an aperture ingeneral alignment with said aperture of said first valve member, andbeing formed of a flexible resilient material at least in the regionadjacent to and defining said aperture; and d) means engageable with theelongated object upon insertion thereof into said proximal inlet openingof said valve body member, and adapted to be radially displaced relativeto a central axis defined by said valve body member to facilitateexpansion of said aperture of said first valve member to facilitateentry of the object therein.
 13. The valve assembly according to claim12 wherein said first and second valve members are formed integral of aflexible elastomeric resilient material, said first valve memberconnected to said second valve member at the proximal end thereof, saidfirst valve member being positioned at least partially within saidsecond valve member.
 14. Valve assembly according to claim 13 whereinsaid proximal end of said first and second valve members is attached toand supported by an annular ring.
 15. Valve assembly according to claim14 wherein said means engageable with the elongated object comprises aplurality of elongated resilient fingers associated with said valvebody, said resilient fingers positioned within said first valve memberin supporting contact with inner surface portions thereof and engageablewith the elongated object upon at least partial insertion of theelongated object into said proximal inlet opening of said valve bodymember, said fingers adapted for radial displacement relative to alongitudinal axis defined by said annular ring upon engagement with theelongated object to radially expand said aperture of said first valvemember to facilitate entry of the elongated object.
 16. Valve assemblyaccording to claim 15 wherein said annular ring member comprises aflexible plastic material selected from the group consisting ofpolyester and polypropylene and said plurality of elongated resilientfingers associated with said valve body are integral with said annularring.
 17. Valve assembly according to claim 16 wherein said meansengageable with the elongated object comprises four of said flexiblefingers.
 18. Valve assembly according to claim 12 further comprisingmanually operable means for selectively opening said aperture of saidsecond valve member whereby the object may pass therethrough.
 19. Valveassembly adapted for introduction of an elongated object into apatient's body, which comprises:a) first valve means formed of aresilient material and defining an aperture for reception of theelongated object, said aperture being configured and dimensioned suchthat insertion of the elongated object into said aperture will cause theresilient material defining said aperture to resiliently engage theouter surface of the elongated object in substantially fluid tightmanner; b) second valve means positioned adjacent said first valve meansin general alignment therewith, said second valve means defining anaperture in general alignment with said aperture of said first valvemeans, and being formed of a flexible material at least in the regiondefining said aperture; c) means associated with said first valve meansand engageable with the elongated object as the elongated object is atleast partially inserted into said aperture of said first valve means,and adapted to be radially displaced to facilitate expansion of saidaperture of said first valve means during introduction of the elongatedobject within the valve assembly; and d) manually operable means toselectively permit said aperture of said second valve means to be openedor closed so as to permit entry of the elongated object.
 20. Valveassembly adapted for introduction of an elongated object into apatient's body, which comprises:a) first valve means formed of aresilient material and defining an aperture for reception of theelongated object, said aperture being configured and dimensioned suchthat insertion of the elongated object into said aperture will cause theresilient material defining said aperture to resiliently engage theouter surface of the elongated object in substantially fluid tightmanner; b) second valve means positioned adjacent said first valve meansin general alignment therewith, said second valve means defining anaperture in general alignment with said aperture of said first valvemeans, and being formed of a flexible material at least in the regiondefining said aperture; c) a plurality of distally extending resilientflexible fingers formed integral with a valve support ring andpositioned within said first valve means in supporting contact withinner surface portions thereof, said fingers configured and dimensionedto engage the elongated object during introduction of the elongatedobject within the valve assembly, whereby engagement of the elongatedobject by said resilient fingers causes radial displacement of saidfingers relative to a longitudinal axis defined by said support ring soas to cause radial expansion of said aperture of said first valve meansto facilitate entry of the elongated object.
 21. Valve assembly forsealed reception of an elongated object, which comprises:a) valve bodydefining at least one opening configured and dimensioned to permit entryof the elongated object; b) flexible resilient valve member defining anaperture positioned in general alignment with said at least one openingin said valve body; and c) at least two relatively rigid membersassociated with said valve member and engageable with the elongatedobject upon introduction into said at least one opening of said valvebody, and adapted to be radially displaced relative to a central axis ofsaid valve body to facilitate expansion of said aperture of saidresilient valve member prior to entry of the elongated object into saidaperture.
 22. Valve assembly for sealed reception of an elongated objectinto a patient's body, which comprises:a) valve body defining a firstinlet opening and a second outlet opening; b) flexible resilient valvemember defining an aperture positioned in general alignment with atleast said first inlet opening for reception of the elongated object,said aperture being configured and dimensioned such that insertion ofthe elongated object into said aperture will cause the flexibleresilient material defining said aperture to resiliently engage andconform to the outer surface of the elongated object in a substantiallyfluid tight manner; and c) means engageable with the elongated objectupon insertion thereof into said first inlet opening and adapted to bedisplaced away from a central axis defined by said valve body to expandsaid aperture of said resilient valve member to facilitate entry of theelongated object therein.
 23. Valve assembly according to claim 22wherein said means engageable with the elongated object comprises valvesupport means, said valve support means being adapted to support saidresilient valve member and including a support ring having at least twodistally extending resilient flexible fingers positioned within saidresilient valve member in supporting contact with the inner surfacethereof, whereby engagement of the elongated object by said at least tworesilient fingers causes radial displacement of said fingers relative toa longitudinal axis defined by said support ring so as to cause radialexpansion of said aperture of said resilient valve member to facilitateentry of the elongated object.
 24. Valve assembly according to claim 23wherein each said flexible finger has a proximal end portion and adistal end portion, each said distal end portion of said flexiblefingers being disposed radially inwardly of said corresponding proximalend portion.
 25. Valve assembly according to claim 24 wherein saiddistal end portions of said flexible fingers are each generallyangularly displaced relative to said longitudinal axis defined by saidsupport ring.
 26. Valve assembly for sealed reception of an elongatedobject, which comprises:a) valve body defining a generally longitudinalaxis and having at least one opening configured and dimensioned topermit entry of the object; flexible resilient valve member positionedwithin said valve body and defining an aperture positioned in generalalignment with said at least one opening of said valve body; and c) atleast two projecting members associated with said flexible resilientvalve member and extending in a generally distal direction, each said atleast two projecting members having at least a portion thereof adaptedto move generally radially to facilitate expansion of said aperture topermit entry of the elongated object therethrough in sealed engagementtherewith.
 27. Valve assembly according to claim 26 wherein each saidprojecting member has a proximal end portion and a distal end portionwhich is disposed generally radially inward of said correspondingproximal end portion.
 28. Valve assembly according to claim 27 whereinportions of said at least two projecting members adapted to moveradially to facilitate said expansion of said aperture are located atthe distal end portions of said projecting members.
 29. Valve assemblyaccording to claim 28 wherein each said distal end portion of saidprojecting members is generally oriented at an angle relative to saidlongitudinal axis.
 30. Valve assembly according to claim 29 wherein saidat least two projecting members contact at least a portion of saidresilient valve member and are positioned for engagement with theelongated object upon insertion thereof into said at least one openingof said valve body, at least portions of said at least two projectingmembers adapted for generally radial displacement relative to saidlongitudinal axis upon engagement by the elongated object to causeradial expansion of said aperture.
 31. Valve assembly according to claim30 wherein said projecting members are attached to an annular ring. 32.Valve assembly according to claim 31 wherein said annular ring comprisesa material selected from the group consisting of polyester andpolypropylene, said projecting members being integrally formed with saidannular ring.
 33. Valve assembly according to claim 32 wherein saidprojecting members are monolithically formed with said annular ring. 34.Valve assembly according to claim 33 wherein at least four of saidprojecting members are provided.
 35. Valve assembly for sealed receptionof an elongated object, which comprises:a) valve body defining an inletopening configured and dimensioned to permit entry of the elongatedobject; b) flexible resilient valve member defining an aperturepositioned in general alignment with said inlet opening; and c) at leastone relatively rigid member having at least a portion thereof adapted tobe displaced radially relative to a central axis defined by said valvebody, said at least a portion of said at least one relatively rigidmember positioned and dimensioned to expand said aperture of saidflexible resilient valve member upon contact with the elongated objectas the elongated object is at least partially inserted into said inletopening.
 36. Valve assembly according to claim 35 comprising at leasttwo said relatively rigid members.
 37. Valve assembly according to claim35 comprising at least four said relatively rigid members.